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Completed

NCT Number: NCT02781675

The Mediterranean Full-Fat Dairy Study

A Mediterranean dietary pattern emphasizing an abundance of plant-based foods including nuts, moderate intakes of fish, poultry and low-fat dairy products, and use of extra virgin olive oil as the main source of fat has been associated with reduced risk of cardiovascular disease (CVD), and such a pattern has been advocated by the 2015 U.S. Dietary Guidelines Advisory Committee. The strongest experimental support for this recommendation derives from the success of the recent PREDIMED CVD outcomes trial, and studies indicating that a Mediterranean-style diet improves lipoprotein and oxidative markers of cardiovascular disease risk in comparison to either low-fat or Western dietary patterns. However, in none of these studies were comparisons made between the effects of Mediterranean-style diets with low-/nonfat vs. full-fat dairy foods. The overall objective of the present proposal is to determine whether the inclusion of full-fat rather than low- and nonfat dairy foods in a Mediterranean dietary pattern based on that used in the PREDIMED study results in similar improvements in biomarkers of CVD risk. Specifically, we will test the hypotheses that 1) a standard Mediterranean diet will lower LDL-C and apoB compared to a Western diet; 2) modification of the Mediterranean diet by replacing low-fat dairy products with high-fat dairy (3 servings/day; high-dairy fat Mediterranean diet) will not significantly increase LDL-C and apoB but may raise large buoyant LDL particles compared with a standard Mediterranean diet; and 3) the high dairy fat and standard Mediterranean diets will result in comparable reductions in levels of inflammatory markers and oxidized LDL, and improvements in endothelial function compared to a Western diet.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cholesterol Research Center

Berkeley, California, 94705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI 25-35 kg/m2
  • Weight stable for > 3 months
  • Agrees to abstain from alcohol or dietary supplements during the study

Exclusion criteria

  • History of coronary heart disease, cerebrovascular disease, peripheral vascular disease, bleeding disorder, liver or renal disease, diabetes, lung disease, HIV, or cancer (other than skin cancer) in the last 5 years.
  • Current use of hormones or drugs knowns to affect lipid metabolism
  • Use of nicotine products or recreational drugs
  • Abnormal TSH
  • Pregnant or breastfeeding
  • Total- and LDL- cholesterol > 95th percentile for sex and age
  • Fasting triglyceride > 500 mg/dl
  • Fasting blood sugar > 126 mg/dl
  • Blood pressure >160/95 mm Hg
  • Allergy to or unwillingness to consume study foods

Treatment and study plan

Dietary Intervention

Other

3 wk dietary intervention with prescribed menus and ~50% foods provided.

Primary outcomes

  1. Plasma LDL-cholesterol

    Time frame: 3 weeks

  2. Plasma Apolipoprotein B

    Time frame: 3 weeks

  3. Plasma Small LDL concentrations

    Time frame: 3 weeks

  4. Plasma Large LDL particle concentrations

    Time frame: 3 weeks

  5. Plasma Total LDL particle concentrations

    Time frame: 3 weeks

Secondary outcomes

  1. Plasma triglycerides

    Time frame: 3 weeks

  2. Plasma HDL-cholesterol

    Time frame: 3 weeks

  3. Plasma apolipoprotein AI

    Time frame: 3 weeks

  4. Plasma oxidized LDL

    Time frame: 3 weeks

  5. Plasma C-reactive protein

    Time frame: 3 weeks

  6. Plasma Interleukin-6

    Time frame: 3 weeks

  7. Plasma Intercellular Adhesion Molecule 1 (ICAM-1)

    Time frame: 3 weeks

  8. Plasma Vascular Cell Adhesion Molecule 1 (VCAM-1)

    Time frame: 3 weeks

  9. RH-PAT index (endothelial function)

    Time frame: 3 weeks

    Endothelial function measured by finger reactive hyperemia peripheral arterial tonography

Sponsors and collaborators

Lead sponsor

UCSF Benioff Children's Hospital Oakland

Other

Collaborators

  • Dairy Management Inc.

Registry information

Official study title

Effects of a Modified High-fat Mediterranean Dietary Pattern on Lipoprotein and Inflammatory Markers of CVD Risk in Adults

Acronym: MFFD

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
May 24, 2016
Registry last updated
Aug 2, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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